Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:59 AM
Study NCT ID:
NCT06820060
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance of QIAstat-Dx® Meningitis/Encephalitis (ME) Panel Plus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D000069544', 'term': 'Infectious Encephalitis'}], 'ancestors': [{'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Fresh Cerebrospinal specimens Selected archived frozen specimens will be tested retrospectively if required.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2025-02-05', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PPA', 'timeFrame': '7 months', 'description': 'Positive percent agreement'}, {'measure': 'NPA', 'timeFrame': '7 months', 'description': 'Negative percent agreement'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Meningitis infection', 'QIAstat-Dx', 'Clinical Performance Study', 'Encephalitis infection'], 'conditions': ['Meningitis', 'Encephalitis Infection']}, 'descriptionModule': {'briefSummary': 'Performance evaluation of QIAstat-Dx® ME Panel Plus using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx® ME Panel Plus achieves its intended performance during normal conditions of use by the intended user in the intended environment', 'detailedDescription': 'The objective of the study is to demonstrate that the QIAstat-Dx® ME Panel Plus achieves its intended performance during normal conditions of use by the intended user in the intended environment.\n\nThe primary objective is to evaluate the performance of QIAstat-Dx® ME Panel Plus in comparison with the results obtained from the reference method.\n\nThe secondary objective of the study is to evaluate the safety of QIAstat-Dx® ME Panel Plus with respect to users/operators.\n\nThe primary study endpoint will be the results for each analyte obtained from testing prospective and retrospective specimens with QIAstat-Dx® ME Panel Plus and Reference Method. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be determined'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with signs and symptoms of Meningitis/Encephalitis infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Specimen must be Cerebrospinal fluid, obtained via lumbar puncture only.\n* Specimen must be a de-identified residual leftover specimen.\n* Specimen must meet the laboratory testing criteria for individuals with signs and/or symptoms of meningitis and/or encephalitis.\n* Specimens must have a minimum 450 µL of residual volume.\n* Specimen must be unique (only one sample enrolled per patient).\n* Prior to QIAstat-Dx testing, residual CSF specimen must have been stored in accordance with the following:\n\n * Prospective Fresh:\n\n * Room temperature (15 °C to 25 °C) for ≤24 hrs\n * Refrigerated (2 °C to 8 °C) for ≤ 7 days\n * Prospective Frozen:\n\n * -15 ºC to -25 ºC for ≤ 2 months\n * -60 ºC to -90 ºC for ≤ 4 months\n * Retrospective Archived:\n\n * Frozen\n* At the time of QIAstat-Dx testing, specimen must not have undergone more than three (3) freeze/thaw cycles.\n* Prospective Samples Only: Specimen must have been collected on or after the date of prospective study activation at the Clinical collection and testing site.\n* Retrospective Samples Only: Specimens must have a positive diagnosis as per Standard of Care for any of the following viral targets:\n\nHerpes simplex virus 1 (HSV-1) Herpes simplex virus 2 (HSV-2) Human herpesvirus 6 (HHV-6) Human parechovirus (HPeV) Varicella zoster virus (VZV) Cytomegalovirus (CMV)\n\nExclusion Criteria:\n\n* Residual CSF specimen has been centrifuged.\n* Residual CSF specimen subject identification or label is unclear or missing.\n* Residual CSF specimen container has obvious physical damage.'}, 'identificationModule': {'nctId': 'NCT06820060', 'briefTitle': 'Clinical Performance of QIAstat-Dx® Meningitis/Encephalitis (ME) Panel Plus', 'organization': {'class': 'INDUSTRY', 'fullName': 'QIAGEN Gaithersburg, Inc'}, 'officialTitle': 'An Observational, Prospective and Retrospective Clinical Study to Evaluate the Performance of QIAstat-Dx® Meningitis/Encephalitis (ME) Panel Plus During Normal Conditions of Use', 'orgStudyIdInfo': {'id': 'DHF-18-0489-1-CSP-003'}}, 'contactsLocationsModule': {'locations': [{'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'QIAGEN', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Sarah Johnson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qiagen Manchester Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QIAGEN Gaithersburg, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}